Fact Sheet
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for obesity. Our lead product candidates reflect a growing understanding of how the CNS regulates appetite and metabolism as well as the mechanisms that limit weight loss over time. Developing new interventions is paramount given the rapidly increasing rates of obesity and serious health consequences (e.g., Type 2 diabetes, heart disease) linked to this chronic disease.
Contrave® – Lead Product Candidate
Contrave is a weight loss medication which has completed Phase 3 clinical trials for the treatment of obesity and has submitted an NDA for FDA review. Contrave has been shown to initiate and sustain significant weight loss over one year of treatment and reduce risk factors associated with diabetes and heart disease.
With its unique mechanism of action in the CNS, Contrave has the potential to change the way obesity is treated by:
- initiating and sustaining weight loss by reducing appetite and increasing metabolism,
- allowing the body to continue losing weight by offsetting its natural tendency to fight back and slowing down the weight loss process and
- possibly being the first treatment for obesity to address the reward system in the brain that causes food cravings.
Contrave is a combination of two well-established drugs, naltrexone and bupropion, in a sustained release formulation (SR) with favorable efficacy, safety and tolerability.
- The active ingredients of Contrave have been safely used in millions of patients for nearly 20 years.
- Bupropion is a well-known, widely-prescribed antidepressant and smoking cessation medication; naltrexone is a treatment for alcohol and opioid addiction.
- Clinical research demonstrates that bupropion helps initiate weight loss while naltrexone may sustain weight loss by preventing the body’s natural tendency to counteract efforts to lose weight.
- This unique combination holds potential to improve symptoms of co-morbid depression, which occurs in approximately 20% of obese patients.
In trials, Contrave has been well tolerated with a side effect profile consistent with similar medications, including nausea, headache and dizziness.
Contrave Phase 2b Highlights
- Patients who completed the trial lost between 8-10.7% in body weight over a 48-week period. This is significant because as little as a 5% reduction in weight has been shown to significantly reduce the risk of developing medical complications of obesity, such as Type II diabetes, heart disease and stroke.
- Contrave demonstrated up to a 50% reduction in the prevalence of metabolic syndrome, which is predictive of Type II diabetes and the development of cardiovascular disease.
- A reduction in insulin resistance was observed, which plays an important role in reducing the incidence of pre-diabetes or Type II diabetes.
- Patients taking Contrave had significant reductions in triglycerides, waist circumference and a significant (up to 8%) increase in HDL (good) cholesterol.
- A 1% increase in HDL results in a 2-3% reduction in cardiovascular risk.
